BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 14571112 · Received June 2, 2022

    Report

    Report Number
    9610877-2022-54078
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 24, 2022
    Report Date
    June 2, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL VNL11-J10 IS AVAILABLE IN THE USA WITH A 510K NUMBER K172156. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE INSERTION FLEXIBLE TUBE (IFT) SPIRAL CLOSER CONDITION. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE INSERTION FLEXIBLE TUBE (IFT). IN ADDITION, WE CONFIRMED THAT THE BENDING RUBBER STRETCHED; HOWEVER, IT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT HR-RPT-0628(IFT) AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. INSERTION FLEXIBLE TUBE (IFT) HARDENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185895 PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown